January 09, 2013 -- Following further successful GMP inspections by FDA and MHRA, Melbourn Scientific has been awarded a Manufacturer's/Importer’s Authorisation (MIA) and is to be named as the EU testing and release site for an aseptically prepared medicinal product on a client’s pending Marketing Authorisation Application.
Melbourn already has an MIA/IMP (Manufacturer's / Importer’s Authorisation for Investigational Medicinal Products) which allows the manufacture and importation of investigational medicinal products.?
Melbourn Scientific has one of largest teams in Europe offering contract research including formulation development, analysis, stability studies and small scale manufacture of clinical trials materials. Carol Barbour, Quality Director says the new licence is a good endorsement of the quality of Melbourn’s procedures and will extend its capabilities.
“With the Manufacturer’s / Importer’s Authorisation (MIA), we will be able to import commercial products which have been manufactured outside the EU and to test them prior to release for sale within the EU/EEA.
“We have secured the services of experienced QPs to audit the supply chain and provide assurance that imported products have been manufactured in accordance with the Marketing Authorisation and GMP. We will also liaise with the wholesale / distribution company to ensure adherence to Good Distribution Practice.
“This extends the scope of our services to cover more of the product lifecycle and will be valued by clients who want to outsource these critical activities. Also with our stability storage capabilities, we are able to provide this service if the client requires on-going stability to be performed in the EU.”
Quality Control testing, which includes stability testing of investigational and marketed medicinal products, is regarded by the MHRA as part of the manufacturing process. So laboratories providing this service need to operate in compliance with the EU Guide to GMP (Good Manufacturing Practice). Melbourn is already GMP certificated so the new licence means that it can offer a complete service including raw material testing, QC and finished product testing and Qualified Person (QP) certification prior to release.
About Melbourn Scientific
Melbourn Scientific, based near Cambridge UK, provides high quality analytical and formulation services to the pharmaceutical and healthcare industry. Clients include major pharmaceutical companies, drug delivery innovators, consultants and virtual companies.
Melbourn Scientific has invested continually in the latest equipment and provides a range of services; formulation and product development; method development and analytical support; stability studies and storage; accelerated feasibility studies, GMP facilities and manufacturing.
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